Reported Jan 20, 2016 · Terminated
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
- Lot codes and dates
Serial numbers 702961702963705644705666and 705947
- Amount recalled
- 5
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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